Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies (PDA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01363531
First received: May 18, 2011
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

The general hypothesis is that delayed antibiotic treatment strategies present similar effectiveness, when compared with non-prescription of antibiotics or the prescription of antibiotics, in the non-complicated acute respiratory tract infections.


Condition Intervention Phase
Pharyngitis
Acute Tonsillitis
Rhinosinusitis
Acute Bronchitis
Chronic Obstructive Pulmonary Disease
Other: Antibiotic prescription strategies
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies in the Non-complicated Acute Respiratory Tract Infections in General Practice

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Duration and severity of symptoms. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Patients completed a diary of symptoms.


Secondary Outcome Measures:
  • Antibiotic consumption at 30 days. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Self-reported by the patients and checked at the Regional Pharmacy's Units.

  • Patient satisfaction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Likert scale

  • Patients' belief in the efficacy of antibiotics [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Likert scale.


Estimated Enrollment: 600
Study Start Date: January 2010
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Direct antibiotic treatment
The doctor gives to patient an antibiotic prescription for his respiratory infection, which he should start immediately.
Other: Antibiotic prescription strategies
The patients enrolled will be randomized between four treatment strategies or arms. Patients randomized to delayed treatment arms or direct treatment, doctors can choose the antibiotic that they consider appropriate depending on such local resistance or practice.
No Intervention: No antibiotic treatment
The doctor doesn't give to patient an antibiotic prescription for his respiratory infection.
Experimental: Delayed antibiotic prescription 1
The doctor gives to patient an antibiotic prescription for his respiratory infection with the advice to use it if needed, in case of worsening of symptoms or not improving.
Other: Antibiotic prescription strategies
The patients enrolled will be randomized between four treatment strategies or arms. Patients randomized to delayed treatment arms or direct treatment, doctors can choose the antibiotic that they consider appropriate depending on such local resistance or practice.
Experimental: Delayed antibiotic prescription 2
The doctor leaves the antibiotic prescription, for the respiratory infection of the patient, at the reception of the primary care center 3 days after the first medical visit. This prescription can be collected by patient if he needed, in case of worsening of symptoms or not improving.
Other: Antibiotic prescription strategies
The patients enrolled will be randomized between four treatment strategies or arms. Patients randomized to delayed treatment arms or direct treatment, doctors can choose the antibiotic that they consider appropriate depending on such local resistance or practice.

Detailed Description:

The aim of the PDA study is to assess the efficacy and safety of different delayed antibiotic prescribing strategies, compared to direct antibiotic treatment and no antibiotic treatment, for the treatment of non-complicated acute respiratory infections, in terms of symptoms duration and severity. Moreover, antibiotic consumption, patient satisfaction, efficacy perception and number of medical visits will be also assessed for each therapeutic strategy.

The PDA is a multicentric study, parallel, randomised controlled trial to compare four antibiotic prescribing strategies in the non-complicated acute respiratory tract infections. The trial will include acute pharyngitis and/or acute tonsillitis, rhinosinusitis, acute bronchitis and acute exacerbation of chronic obstructive pulmonary disease with (mild to moderate) in adults. The expected number of patients to be included in this trial is 600. Therapeutic strategies include: direct antibiotic treatment, no antibiotic treatment, and two delayed antibiotic prescribing strategies (prescription given to patient with advice to use a course of antibiotics if needed in case of worsening of symptoms or not improving, and prescription left at the reception of the primary care center 3 days after the first medical visit). Follow-up period will be one month. The primary outcome will be symptom duration and severity. Other outcomes included will be use of antibiotics, patient satisfaction, perception of antibiotic efficacy, complications, and number of medical visits.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

In this study can be enrolled adult patients with non-complicated acute respiratory tract infections, including pharyngitis and/or tonsillitis, rhinosinusitis, acute bronchitis and exacerbations of chronic obstructive pulmonary disease mild to moderate. The doctors include patients with these infections if they have reasonable doubts if the patients should treat with antibiotics

General Exclusion Criteria:

  • Patients have participated in the PDA previously.
  • Patients are severely affected or patients has been felt severely affected for a week (all time)
  • Patients with symptoms and signs suggestive of serious illness or severely affected and/or complications (particularly pneumonia, mastoiditis, peritonsillar abscess, peritonsillar cellulitis, intraorbital or intracranial complications).
  • Patients at high risk of serious complications due to prior comorbidity. This includes significant heart disease, lung, kidney, liver or neuromuscular, immunosuppression, cystic fibrosis.
  • If the patient is over 65 years with acute cough and two or more of the following criteria or more than 80 years with acute cough and one or more of the following criteria:
  • Hospitalization in the previous year
  • Diabetes Type I or II
  • History of heart failure
  • Current use of oral corticosteroids.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363531

Locations
Spain
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Pablo Alonso Coello, PhD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

Additional Information:
No publications provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01363531     History of Changes
Other Study ID Numbers: PDA study
Study First Received: May 18, 2011
Last Updated: March 19, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Prescription
Antibiotic
Acute respiratory infections
Satisfaction
Perception
Pharyngitis and/or acute tonsillitis
Rhinosinusitis
Acute bronchitis
Acute exacerbation of chronic obstructive pulmonary disease (mild to moderate)

Additional relevant MeSH terms:
Peritonsillar Abscess
Bronchitis
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Pharyngitis
Respiratory Tract Infections
Tonsillitis
Acute Disease
Lung Diseases, Obstructive
Sinusitis
Abscess
Suppuration
Infection
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Bronchial Diseases
Disease Attributes
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 16, 2014